Material Safety Data Sheet. Sterile Pharmaceutical Clean Room Formula



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Transcription:

DECON-SPORE 200 Plus Sterile Pharmaceutical Clean Room Formula MATERIAL SAFETY DATA SHEET COMPLIES WITH OSHA HAZARD COMMUNICATIONS STANDARD 29 CFR 1910.1200 (Complies with Commission Directive 91/155/EEC amended by 2001/58/EC) Veltek Associates, Inc. 15 Lee Boulevard, Malvern, PA 19355-1234 USA T: 610-644-8335 F: 610-644-8336 www.sterile.com Page 1 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009

* * * Section 1 - Chemical Product and Company Identification * * * Manufacturer Information Veltek Associates, Inc. Phone: 610-644-8335 15 Lee Blvd. Fax: 610-644-8336 Malvern, PA USA 19355-1234 (Emergency) FIRST RESPONDERS: For Spill/Exposure Emergency Response Service in English, French, Spanish (and 23 other languages) telephone CHEMCARE24 at 011+44 208 762 8322, for Arabic language 001+961 3 487 287 or Chinese 001+86 10 5100 3039. * * * Section 2 - Hazards Identification * * * Emergency Overview Corrosive. May cause severe irritation or burns to the eyes, skin, gastrointestinal tract, and respiratory system. Harmful or fatal if swallowed. Oxidizer. May ignite or explode on contact with combustible materials. Potential Health Effects: Eyes Corrosive. Concentrate is severely irritating to the eyes and can cause eye burns and irreversible eye damage. Potential Health Effects: Skin Corrosive This product is severely irritating to the skin and can cause burns. May be fatal if absorbed through skin. Potential Health Effects: Ingestion Harmful or fatal if swallowed. Ingestion may produce burns to the lips, oral cavity, upper airway, esophagus and possibly the digestive tract. Potential Health Effects: Inhalation This product is severely irritating to the respiratory system. May be fatal if inhaled. Symptoms may nclude burning taste, sneezing, coughing and difficulty breathing. Medical Conditions Aggravated by Exposure Persons with asthma or lung problems may be more susceptible to the effects of inhalation of this product. HMIS Ratings: Health: 3 Fire: 2 Physical Hazard: 1 Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate 3 = Serious 4 = Severe * = Chronic hazard * * * Section 3 - Composition / Information on Ingredients * * * CAS # Component Percent 7722-84-1 Hydrogen peroxide 30-60 64-19-7 Acetic acid 7-13 79-21-0 Peroxyacetic acid 7-13 Component Information/Information on Non-Hazardous Components This product is considered hazardous under 29 CFR 1910.1200 (Hazard Communication). This is a controlled product according to Canada's Controlled Product Regulation. Page 2 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009

* * * Section 4 - First Aid Measures * * * First Aid: Eyes Immediately flush eyes with water for at least 15 minutes, while holding eyelids open. Remove contact lenses. Seek medical attention at once. First Aid: Skin Flush skin with plenty of water and wash well with soap and water. Remove contaminated clothing and launder clothing before reuse. Obtain medical attention. First Aid: Ingestion Do not induce vomiting. Call a physician or poison control center immediately. First Aid: Inhalation If inhaled, immediately remove the affected person to fresh air. Call a physician immediately. * * * Section 5 - Fire Fighting Measures * * * General Fire Hazards See Section 9 for Flammability Properties. Oxidizing agent, may cause spontaneous ignition of combustible materials. Combustible liquid and vapor. Hazardous Combustion Products Oxygen, Oxides of Carbon. Extinguishing Media Water. Specific Hazards Arising From the Chemical Product decomposes and will release oxygen thereby adding to the hazard of a fire. Product should be kept cool and in a vented container to avoid explosion hazards. Fire Fighting Equipment/Instructions Firefighters should wear full protective clothing including self contained breathing apparatus. NFPA Ratings: Health: 3 Fire: 2 Reactivity: 1 Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate 3 = Serious 4 = Severe * * * Section 6 - Accidental Release Measures * * * Containment Procedures Stop the flow of material, if this is without risk. Remove all sources of ignition. Clean-Up Procedures Ventilate the contaminated area. Use non-sparking tools when opening or closing containers. Rinse small amounts with copious amounts of water to drain where possible. For larger spills: Absorb spill with inert material. Shovel material into appropriate container for disposal. Thoroughly wash the area with water after a spill or leak clean-up. Evacuation Procedures Isolate area. Keep unnecessary personnel away. Special Procedures No additional information available. * * * Section 7 - Handling and Storage * * * Handling Procedures Product bottles incorporate a vented cap; do NOT invert bottles. Do not get this material in contact with skin or eyes and clothing. Do not reuse the empty container. Page 3 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009

Storage Procedures Manufacturer recommends storing above 40 F (4.4 C) and below 90 F(32.2 C). Keep the container tightly closed. Keep away from incompatible materials. * * * Section 8 - Exposure Controls / Personal Protection * * * A: Component Exposure Limits ACGIH: OSHA (Final): OSHA (Vacated): NIOSH: Alberta: British Columbia: Manitoba: New Brunswick: NW Territories: Nova Scotia: Nunavut: Ontario: Quebec: Saskatchewan: Yukon: 2 ppm STEL; 2.8 mg/m3 STEL 2 ppm STEL; 2.8 mg/m3 STEL EV; 1.4 mg/m3 TWAEV EV; 1.4 mg/m3 TWAEV 2 ppm STEL ; 1.5 mg/m3 TWA 2 ppm STEL; 2.8 mg/m3 STEL Acetic acid (64-19-7) ACGIH: 10 ppm TWA OSHA (Final): 10 ppm TWA; 25 mg/m3 TWA OSHA (Vacated): 10 ppm TWA; 25 mg/m3 TWA NIOSH: 10 ppm TWA; 25 mg/m3 TWA ; 37 mg/m3 STEL Alberta: 10 ppm TWA; 25 mg/m3 TWA ; 37 mg/m3 STEL British Columbia: 10 ppm TWA Manitoba: 10 ppm TWA New Brunswick: 10 ppm TWA; 25 mg/m3 TWA ; 37 mg/m3 STEL NW Territories: 10 ppm TWA; 26 mg/m3 TWA ; 39 mg/m3 STEL Nova Scotia: 10 ppm TWA Nunavut: 10 ppm TWA; 26 mg/m3 TWA ; 39 mg/m3 STEL Ontario: 10 ppm TWAEV; 25 mg/m3 TWAEV 15 ppm STEV; 37 mg/m3 STEV Quebec: 10 ppm TWAEV; 25 mg/m3 TWAEV 15 ppm STEV; 37 mg/m3 STEV Page 4 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009

Saskatchewan: Yukon: 10 ppm TWA 10 ppm TWA; 25 mg/m3 TWA 25 ppm STEL; 43 mg/m3 STEL Engineering Controls Use local exhaust ventilation. PERSONAL PROTECTIVE EQUIPMENT Personal Protective Equipment: Eyes/Face Wear chemical goggles; face shield (if splashing is possible). Personal Protective Equipment: Skin Rubber gloves, those with protective cuff or gauntlet preferred. Personal Protective Equipment: Respiratory If ventilation is not sufficient to effectively prevent buildup of vapors, use appropriate NIOSH/MSHA respiratory protection. Personal Protective Equipment: General Eye wash fountain and emergency showers are recommended. * * * Section 9 - Physical & Chemical Properties * * * Appearance: Clear liquid Odor: Sharp, pungent Physical State: Liquid ph: 2.5 (1%) Vapor Pressure: Not available Vapor Density: Not Available Boiling Point: 200 F (93.3 C) Melting Point: Not available Solubility (H2O): Miscible Specific Gravity: 1.12 Evaporation Rate: Not available Octanol/H2O Coeff.: Not available Upper Flammability Limit (UFL): Not Available Lower Flammability Limit (LFL): Not Available Flash Point Method: 181 F (83 C) Burning Rate: Not Available Auto Ignition: 518 F (270 C) * * * Section 10 - Chemical Stability & Reactivity Information * * * Chemical Stability Stable under controlled conditions of handling and storage. Chemical Stability: Conditions to Avoid Do not mix with anything but water. Avoid excessive heat and ignition sources Incompatibility This product is an OXIDIZING AGENT - avoid contact with organic material. Avoid contact with organic material, strong bases, reducing agents, iron and copper. Do not mix with halogenated materials- may release toxic gases. Hazardous Decomposition Upon decomposition, this product emits carbon monoxide, carbon dioxide and/or low molecular weight hydrocarbons. Product decomposes and will release oxygen thereby adding to the hazard of a fire. Possibility of Hazardous Reactions Minimal with controlled conditions. * * * Section 11 - Toxicological Information * * * Acute Dose Effects HARMFUL OR FATAL IF SWALLOWED. Acute exposure may cause severe irritation or burns to the eyes, skin, gastrointestinal tract, and respiratory system. Causes eye damage. Page 5 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009

B: Component Analysis - LD50/LC50 Inhalation LC50 Rat 2 mg/l 4 h; Oral LD50 Rat 801 mg/kg; Dermal LD50 Rat 4060 mg/kg; Dermal LD50 Rabbit 2000 mg/kg Acetic acid (64-19-7) Inhalation LC50 Rat 11.4 mg/l 4 h; Oral LD50 Rat 3310 mg/kg; Dermal LD50 Rabbit 1060 mg/kg Peroxyacetic acid (79-21-0) Inhalation LC50 Rat 0.3 mg/l 1 h; Oral LD50 Rat 263 mg/kg; Dermal LD50 Rabbit 1410 µl/kg; Dermal LD50 Rat 12000 mg/kg Repeated Dose Effects Repeated or prolonged exposure may cause severe irritation, burns, conjunctivitis, and dermatitis. Carcinogenicity No carcinogenicity data available for this product. B: Component Carcinogenicity ACGIH: A3 - Confirmed Animal Carcinogen with Unknown Relevance to Humans IARC: Monograph 71 [1999]; Supplement 7 [1987]; Monograph 36 [1985] (Group 3 (not classifiable)) Target Organ Effects Can cause burns to the eyes with irreversible damage, skin, gastrointestinal tract and respiratory tract. Other Toxicological Information None identified. * * * Section 12 - Ecological Information * * * Ecotoxicity This product may decrease ph of waterways and adversely affect aquatic life. B: Component Analysis - Ecotoxicity - Aquatic Toxicity Test & Species Conditions 96 Hr LC50 Pimephales promelas 16.4 mg/l 96 Hr LC50 Lepomis macrochirus 18-56 mg/l Static 96 Hr LC50 Oncorhynchus mykiss 10.0-32.0 mg/l Static 72 Hr EC50 Chlorella vulgaris 2.5 mg/l 24 Hr EC50 Daphnia magna 7.7 mg/l 48 Hr EC50 Daphnia magna 18-32 mg/l Static Acetic acid (64-19-7) Test & Species Conditions 96 Hr LC50 Pimephales promelas 79 mg/l Static 96 Hr LC50 Lepomis macrochirus 75 mg/l Static 24 Hr EC50 Daphnia magna 47 mg/l 48 Hr EC50 Daphnia magna 65 mg/l Static Page 6 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009

* * * Section 13 - Disposal Considerations * * * US EPA Waste Number & Descriptions If discarded, this product is considered a RCRA corrosive waste, D002. B: Component Waste Numbers No EPA Waste Numbers are applicable for this product's components. Disposal Instructions Pesticide wastes are acutely hazardous. Contact a Pesticide or Environmental Control Agency. Dispose of waste material according to Local, State, Federal, and Provincial Environmental Regulations. See Section 7 for Handling Procedures. See Section 8 for Personal Protective Equipment recommendations. * * * Section 14 - Transportation Information * * * US DOT Information Shipping Name: Organic peroxide, type F, liquid (Peroxyacetic Acid, Type F, stabilized) UN/NA #: UN 3109 Hazard Class: 5.2 Packing Group: II Required Label(s): Organic Peroxide TDG Information Shipping Name: Organic peroxide, type F, liquid (Peroxyacetic Acid, Type F, stabilized) UN/NA #: UN3109 Hazard Class: 5.2 Packing Group: II Required Label(s): Organic Peroxide * * * Section 15 - Regulatory Information * * * US Federal Regulations This is an EPA registered pesticide (EPA registration No. 1677-129-068959). It is a violation of Federal law to use this product in a manner inconsistent with the EPA registered label. All components are on the U.S. EPA TSCA Inventory List. B: Component Analysis This material contains one or more of the following chemicals required to be identified under SARA Section 302 (40 CFR 355 Appendix A), SARA Section 313 (40 CFR 372.65) and/or CERCLA (40 CFR 302.4). SARA 302: 1000 lb TPQ (concentration >52%) Acetic acid (64-19-7) CERCLA: 5000 lb final RQ; 2270 kg final RQ Peroxyacetic acid (79-21-0) SARA 302: 500 lb TPQ SARA 313: 1.0 % de minimis concentration SARA 311/312 Acute: Yes Chronic: No Fire: Yes Pressure: No React: No Page 7 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009

State Regulations State and Provincial regulations may apply. Check individual requirements. B: Component Analysis - State The following components appear on one or more of the following state hazardous substances lists: Component CAS CA MA MN NJ PA RI Hydrogen peroxide 7722-84-1 Yes Yes Yes Yes Yes Yes Acetic acid 64-19-7 Yes Yes Yes Yes Yes Yes Peroxyacetic acid 79-21-0 No Yes No Yes Yes Yes Canadian WHMIS Information WHMIS Classification: Class C- Oxidizing Material, Class E- Corrosive Material. B: Component Analysis - WHMIS IDL The following components are identified under the Canadian Hazardous Products Act Ingredient Disclosure List: Component CAS # Minimum Concentration Hydrogen peroxide 7722-84-1 1 % Acetic acid 64-19-7 1 % Peroxyacetic acid 79-21-0 1 % Additional Regulatory Information No additional information available. B: Component Analysis - Inventory Component CAS # TSCA CAN EEC Hydrogen peroxide 7722-84-1 Yes DSL EINECS Acetic acid 64-19-7 Yes DSL EINECS Peroxyacetic acid 79-21-0 Yes DSL EINECS * * * Section 16 - Other Information * * * Other Information No additional information available. MSDS History Revision 2.0000: Formulation change: 9 November 2009. Revision 1.0000: New MSDS: 3 January 2005. Page 8 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009

Key/Legend ACGIH = American Conference of Governmental Industrial Hygienists; CERCLA = Comprehensive Environmental Response, Compensation and Liability Act; CFR = Code of Federal Regulations; CNS = Central Nervous System; DSL = Domestic Substances List; EINECS = European Inventory of Existing Commercial Chemical Substances; EPA = Environmental Protection Agency; HEPA = High Efficiency Particulate Air filters; IARC = International Agency for Research on Cancer; LC50 = Lethal Concentration 50%; LD50 = Lethal Dose 50%; NIOSH = National Institute for Occupational Safety and Health; NJTSR = New Jersey Trade Secret Registry; NTP = National Toxicology Program; OSHA = Occupational Safety and Health Administration; PEL = Permissible Exposure Limit; RCRA = Resource Conservation and Recovery Act; SARA = Superfund Amendments and Reauthorization Act; STEL = Short Term Exposure Limit; TDG = Transport Dangerous Goods TSCA = Toxic Substance Control Act; TWA = Time Weighted Average; WHMIS = Workplace Hazardous Materials Information System. End of Sheet DS200-0397-01-01 Page 9 of 9 Issue Date: 11/09/09 Revision: 2.0000 Print Date: 12/3/2009